Basket style cardiac mapping catheter having a flexible electrode assembly for sensing monophasic action potentials

• US 9,504,399 B2
• Filed: 06/28/2013
• Issued: 11/29/2016
• Est. Priority Date: 04/22/2011
• Status: Active Grant

• Current Assignee: Topera, Inc (Abbott Laboratories)
• Original Assignee: Topera, Inc (Abbott Laboratories)
• Inventors: Kordis, Thomas F., Johnson, Eric T., Burke, Phillip C., Kent, Darrin J., Magrini, Kevin M., Burke, Jeff A., Ragland, Robert Ryan
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): ANTISKAY, BRIAN MICHAEL
• Application Number:
  US13/929,838
• Publication Number:
  US 20130331677A1
• Time in Patent Office: 1,250 Days
• Field of Search: 600372-375, 600/381, 600/393, 600/509, 600/523, 606 41- 50, 607/116, 607/119, 607/122
• US Class Current: 1/1
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2562/17 Comprising radiolucent components
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/6858 with a distal basket, e.g. expandable basket
• CPC Class Codes: A61B 5/6859 with multiple distal splines
• CPC Class Codes: F04C 2270/0421 Controlled or regulated
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

A system for sensing monophasic action potentials from endocardial tissue of a heart, includes: a plurality of flexible splines; an anchor for securably affixing the proximal portions of the splines; a tip for securably affixing the distal portions of the splines; and a polymeric member including opposed a first open end and a second open end defining an open lumen therein between, where at least one of the plurality of flexible splines is at least partially disposed within the lumen of the polymeric member; a flexible electrode assembly strip with two or more exposed electrodes oppositely disposed on at least a portion of the outer surface of the polymeric member.

Claims

1. A system for sensing monophasic action potentials from endocardial tissue of a heart, comprising:

a first elongate tubular member having a lumen, a proximal end and a distal end;

a basket assembly comprising;

a plurality of flexible splines having proximal portions, distal portions and medial portions therein between, wherein the splines comprise an outer surface, an inner surface and two side surfaces;

a proximal anchor for securably affixing the proximal portions of the splines, wherein the anchor is securably affixed within the lumen of the elongate tubular member at the distal end of the first elongate tubular member;

a tip for securably affixing the distal portions of the splines; and

a polymeric member comprising opposed first and second open ends defining an open lumen therein between and an inner member surface and an outer member surface, wherein at least one of the plurality of flexible splines is at least partially disposed within the lumen of said polymeric member;

a flexible electrode assembly strip having a longitudinal length with two or more laterally extending and staggered wings, each of said wings having an exposed electrode, the flexible electrode assembly strip being directly disposed on at least a portion of the outer surface of said polymeric member;

wherein the flexible electrode assembly strip comprises;

a polymeric substrate having an inner surface and an opposed outer surface;

said two or more exposed electrodes directly disposed over at least part of the outer surface of the polymeric substrate; and

two or more electrical traces directly disposed over at least a portion of the inner surface of the polymeric substrate or over at least a portion of the outer surface of the polymeric substrate, said two or more electrical traces being in electrical communication with said two or more exposed electrodes;

wherein at least one of the two or more exposed electrodes is disposed over at least part of the outer surface of the polymeric member which is adjacent to the outer surface of the spline and the other of the two or more exposed electrodes is disposed over at least another part of the outer surface of the polymeric member which is adjacent to the inner surface of the spline;

wherein the first opposed open end of the polymeric member is disposed at the distal spline portion of said at least one of the plurality of flexible splines at a position near to the distal tip and the second opposed open end of the polymeric member is secured to the proximal spline portion of said at least one of the plurality of flexible splines at a position near to the anchor;

wherein medial portions of the polymeric member between said first opposed open end and said second opposed open end of the polymeric member are not secured to said medial portions of said at least one of the plurality of flexible splines;

wherein the basket assembly has a radially expanded non-cylindrical shape; and

wherein the splines comprise a superelastic material.

2. The system of claim 1, further comprising:

a second elongate tubular member having a lumen, a proximal end and a distal end;

wherein the basket assembly is slidingly compressible to fit within the lumen of the second elongate tubular member;

wherein the basket assembly has a substantially cylindrical shape when compressed within the lumen of the second elongate tubular member; and

wherein the basket assembly has said radially expanded non-cylindrical shape when not compressed within the lumen of the second elongate tubular member and disposed past the distal end of the second elongate tubular member.

3. The system of claim 1, wherein the splines further comprise spline ends and further wherein the spline ends terminate at the proximal portions of the splines.

4. The system of claim 1, further comprising:

a plurality of polymeric members; and

a plurality of flexible electrode assembly strips;

wherein each one of said plurality of polymeric members have at least one of said plurality of flexible electrode assembly strips;

wherein each one of said plurality of flexible splines is at least partially disposed within one of said plurality of polymeric members; and

wherein each of said plurality of splines has a different one of said plurality of polymeric members.

5. The system of claim 4, wherein each of the flexible electrode assembly strips is compressed into the outer surface of the different one of each of said polymeric members;

and

wherein each of the flexible electrode assembly strips is thermally or adhesively bonded to the outer surface of the different one of each of said polymeric members.

6. The system of claim 1, wherein said two or more electrical traces are directly disposed over at least a portion of the inner surface of the polymeric substrate and further comprising vias to provide said electrical communication between said two or more electrical traces and said two or more exposed electrodes.

7. The system of claim 1, wherein said two or more electrical traces are directly disposed over at least a portion of the outer surface of the polymeric substrate and further comprising a polymeric covering over the outer surface of the polymeric substrate and said electrical traces with the two or more exposed electrodes being substantially free of the polymeric covering.

8. The system of claim 1, wherein said two or more exposed electrodes comprise a metal selected from the group consisting of copper, gold, platinum, platinum black, platinum-iridium and combinations thereof.

9. The system of claim 1, wherein the outer surface and the inner surface of said plurality of flexible splines are substantially flat surfaces and the two side surfaces of said plurality of flexible splines are convexly rounded surfaces.

10. The system of claim 1, wherein said at least one of the two or more exposed electrodes which is disposed over at least part of the outer surface of the polymeric member which is adjacent to the outer surface of the spline is configured to intimately contact endocardial tissue.

11. The system of claim 10, wherein said at least one of the two or more exposed electrodes which is disposed over at least part of the outer surface of the polymeric member which is adjacent to the outer surface of the spline is raised above at least part of the outer surface of the polymeric substrate of the flexible electrode assembly strip.

12. The system of claim 1, wherein a portion of the flexible electrode assembly transitions from the outer surface of said polymeric member in a direction towards the inner surface of said polymeric member prior to said anchor;

and

wherein another portion of the flexible electrode assembly extends through at least a portion of said anchor and into said lumen of said elongate tubular member.

13. A system for sensing monophasic action potentials from endocardial tissue of a heart, comprising:

a first elongate tubular member having a lumen, a proximal end and a distal end;

a basket assembly comprising;

a plurality of flexible splines having proximal portions, distal portions and medial portions therein between, wherein the splines comprise an outer surface, an inner surface and two side surfaces;

a proximal anchor for securably affixing the proximal portions of the splines, wherein the anchor is securably affixed within the lumen of the elongate tubular member at the distal end of the first elongate tubular member;

a tip for securably affixing the distal portions of the splines; and

a polymeric member comprising opposed first and second open ends defining an open lumen therein between and an inner member surface and an outer member surface, wherein at least one of the plurality of flexible splines is at least partially disposed within the lumen of said polymeric member;

a flexible electrode assembly strip having a longitudinal length with two or more laterally extending and staggered wings, each of said wings having an exposed electrode, the flexible electrode assembly strip being directly disposed on at least a portion of the outer surface of said polymeric member;

wherein the flexible electrode assembly strip comprises;

a polymeric substrate having an inner surface and an opposed outer surface;

said two or more exposed electrodes directly disposed over at least part of the outer surface of the polymeric substrate; and

two or more electrical traces directly disposed over at least a portion of the inner surface of the polymeric substrate or over at least a portion of the outer surface of the polymeric substrate, said two or more electrical traces being in electrical communication with said two or more exposed electrodes;

wherein at least one of the two or more exposed electrodes is disposed over at least part of the outer surface of the polymeric member which is adjacent to the outer surface of the spline and the other of the two or more exposed electrodes is disposed over at least another part of the outer surface of the polymeric member which is adjacent to the inner surface of the spline;

wherein a portion of the flexible electrode assembly transitions from the outer surface of said polymeric member in a direction towards the inner surface of said polymeric member prior to said anchor;

wherein another portion of the flexible electrode assembly extends through at least a portion of said anchor and into said lumen of said elongate tubular member;

wherein the basket assembly has a radially expanded non-cylindrical shape; and

wherein the splines comprise a superelastic material.

14. The system of claim 13, further comprising:

a second elongate tubular member having a lumen, a proximal end and a distal end;

wherein the basket assembly is slidingly compressible to fit within the lumen of the second elongate tubular member;

wherein the basket assembly has a substantially cylindrical shape when compressed within the lumen of the second elongate tubular member; and

wherein the basket assembly has said radially expanded non-cylindrical shape when not compressed within the lumen of the second elongate tubular member and disposed past the distal end of the second elongate tubular member.

15. The system of claim 13, wherein the splines further comprise spline ends and further wherein the spline ends terminate at the proximal portions of the splines.

16. The system of claim 13, further comprising:

a plurality of polymeric members; and

a plurality of flexible electrode assembly strips;

wherein each one of said plurality of polymeric members have at least one of said plurality of flexible electrode assembly strips;

wherein each one of said plurality of flexible splines is at least partially disposed within one of said plurality of polymeric members; and

wherein each of said plurality of splines has a different one of said plurality of polymeric members.

17. The system of claim 16, wherein each of the flexible electrode assembly strips is compressed into the outer surface of the different one of each of said polymeric members;

and

wherein each of the flexible electrode assembly strips is thermally or adhesively bonded to the outer surface of the different one of each of said polymeric members.

18. The system of claim 13, wherein said two or more electrical traces are directly disposed over at least a portion of the inner surface of the polymeric substrate and further comprising vias to provide said electrical communication between said two or more electrical traces and said two or more exposed electrodes.

19. The system of claim 13, wherein said two or more electrical traces are directly disposed over at least a portion of the outer surface of the polymeric substrate and further comprising a polymeric covering over the outer surface of the polymeric substrate and said electrical traces with the two or more exposed electrodes being substantially free of the polymeric covering.

20. The system of claim 13, wherein said two or more exposed electrodes comprise a metal selected from the group consisting of copper, gold, platinum, platinum black, platinum-iridium and combinations thereof.

21. The system of claim 13, wherein the outer surface and the inner surface of said plurality of flexible splines are substantially flat surfaces and the two side surfaces of said plurality of flexible splines are convexly rounded surfaces.

22. The system of claim 13, wherein said at least one of the two or more exposed electrodes which is disposed over at least part of the outer surface of the polymeric member which is adjacent to the outer surface of the spline is configured to intimately contact endocardial tissue.

23. The system of claim 22, wherein said at least one of the two or more exposed electrodes which is disposed over at least part of the outer surface of the polymeric member which is adjacent to the outer surface of the spline is raised above at least part of the outer surface of the polymeric substrate of the flexible electrode assembly strip.

24. The system of claim 13,

wherein the first opposed open end of the polymeric member is disposed at the distal spline portion of said at least one of the plurality of flexible splines at a position near to the distal tip and the second opposed open end of the polymeric member is secured to the proximal spline portion of said at least one of the plurality of flexible splines at a position near to the anchor;

and

wherein medial portions of the polymeric member between said first opposed open end and said second opposed open end of the polymeric member are not secured to said medial portions of said at least one of the plurality of flexible splines.